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Drug product development and cmc leader

Planet Pharma
Publiée le 17 juillet
Description de l'offre

Job Title: Drug Product Development and CMC Leader (Contract – 7 Months) Start Date: End of July/ Mid-August Duration: Until end of March 2026 Workload: Full-time (or minimum 80%) Role Summary Our client is currently seeking a highly experienced Drug Product Development and CMC Leader to join their team. This is a unique opportunity to contribute to a late-phase small molecule development project currently transitioning from Phase 2 (capsule) to Phase 3 (tablet). You will play a key role in managing outsourced development and clinical bulk supply activities, while shaping the formulation and manufacturing strategy. As the Drug Product (DP) Development Leader, you will: Lead the DP development and clinical supply strategy for a late-phase project. Represent CMC in the project team and align strategy, planning, and execution. Manage the CMC budget and oversee the execution of the CMC development plan. Supervise manufacturing of development and GMP batches. Evaluate formulation/process data and adjust strategies as needed. Oversee stability studies and regulatory documentation. Manage external service providers (ESPs) and ensure compliance with cGMP. Collaborate with internal Quality and Compliance teams. Support due diligence activities when required. Your Profile MSc or PhD in Chemistry, Pharmaceutical Sciences, Bio-Engineering, or equivalent experience. Minimum 10 years of experience in drug product development. Deep expertise in solid oral formulation development. Proven experience working with CROs and in cross-functional teams. Strong leadership, communication, and organizational skills. Fluent in English (written and spoken). Hands-on, pragmatic, and solution-oriented. If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Femi Olubodun via telephone on 44 (0) 2039288387 or email on: folubodun@planet-pharma.co.uk If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help! About Planet Pharma Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30 countries with a current network of 2500 active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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